The BioPharm Brief: Earlier Treatment, New Testing, and Sjögren’s Data

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here’s what we have today.

First, FDA has expanded the US label for Merck’s Winrevair. The update adds data from the Phase 3 HYPERION trial in adults diagnosed with pulmonary arterial hypertension within the previous 12 months. Adding Winrevair to background therapy reduced the risk of clinical worsening events by 76% compared with placebo, supporting its use earlier in the treatment course.

FDA is also formally recognizing non-animal testing methods. A new direct final rule updates regulatory language to clarify that methods such as human cells, organoids, organs-on-chips, and computer models can be used when appropriate to generate nonclinical safety information. The rule does not eliminate animal studies, and developers still need to demonstrate that an alternative method is fit for purpose.

And Amgen’s dazodalibep has hit its Phase 3 primary endpoint in Sjögren disease. The OASIZ 301 trial showed statistically significant and clinically meaningful improvement in systemic disease activity at week 48, with improvements seen as early as week 4. Dazodalibep is a CD40 ligand antagonist, and Amgen says a second Phase 3 trial is expected to read out in the fourth quarter.

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Key takeaways

• FDA expands Winrevair’s label for patients with recently diagnosed pulmonary arterial hypertension.
• FDA formalizes non-animal testing methods, including emerging approaches such as organoids and organs-on-chips.
• Amgen’s dazodalibep hits its Phase 3 endpoint in Sjögren disease, advancing a potential new treatment option.